In a study reported in the Journal of Oncology Practice, Chan Shen, PhD, of The University of Texas MD Anderson Cancer Center, and colleagues found that more than three-quarters of patients receiving targeted oral therapy for chronic myeloid leukemia (CML) reached the catastrophic phase of the Medicare Part D benefit within the calendar year of starting such treatment.

In the study, 898 patients with CML who were new oral targeted therapy users were identified from linked Surveillance, Epidemiology, and End Results (SEER) registry–Medicare Part D data for 2007 to 2012. Out-of-pocket payments and gross drug costs were analyzed for the calendar year of starting treatment.

Overall, 32% of patients participated in a managed-care organization or regional preferred provider organization and 68% in a Medicare prescription drug plan. According to cost share group, 25% were heavily subsidized, 14% were moderately subsidized, and 61% had no subsidy.

Pattern of Financial Burden

Overall, 726 patients (81%) reached the catastrophic phase of the Medicare Part D benefit within the year of starting medication, with most patients reaching this phase within 1 month. The percentage of patients reaching the catastrophic phase remained at ≥ 80% throughout the year, except for patients starting medication in December (47%). Patients who started therapy later in the calendar year had incurred higher out-of-pocket payments before starting targeted medication.

For patients without subsidies, there was a clear pattern of a spike in out-of-pocket payments in the month of starting treatment; payments decreased thereafter and became stable at approximately $200 per month (approximately 10% of the spike value). Out-of-pocket payments for patients with subsidies were markedly lower. For all patients, monthly gross drug costs increased markedly in the starting month and remained high thereafter, with little difference in these costs for patients with vs without subsidies. Examination of out-of-pocket payments and gross drug costs for a 30-day supply of medication averaged over all fills in the year showed a substantial variation in payments; the median payment was $183 per 30-day supply, with > 25% of patients paying < $2 and the top quartile paying > $912. For gross drug costs, the majority of patients fell between $3,632 (10th percentile) and $8,429 (90th percentile).

The investigators concluded: “Patients experience quick entry and exit from the coverage gap (also called the donut hole) as a result of the high price of [targeted oral anticancer medications]. Closing the donut hole will provide financial relief during the initial month(s) of treatment but will not completely eliminate the financial burden.”

The study was supported by the Duncan Family Institute, the Agency for Healthcare Research and Quality, and the National Cancer Institute. ■